Have J&J's Approval Hopes Vanished?

Acute coronary syndrome might not be the biggest market for Johnson & Johnson's (NYS: JNJ) Xarelto -- the blood thinner is already approved to prevent blood clots after surgery and to treat atrial fibrillation, a type of irregular heart beat -- but it could be the most important.

Xarelto is likely to see competition from Bristol-Myers Squibb (NYS: BMY) and Pfizer's (NYS: PFE) blood thinner called Eliquis, which most people view as the best drug for atrial fibrillation. But in acute coronary syndrome, bleeding caused by Eliquis trumped any efficacy benefit, leaving room for Xarelto to move in.

A decision on Eliquis in atrial fibrillation is expected on June 28. A day later, the Food and Drug Administration is expected to make a decision about Xarelto in acute coronary syndrome. Unfortunately it looks as if Johnson & Johnson might have a hard time sidestepping the competition into the new indication.

An advisory panel voted 6-4 with one abstention on Wednesday recommending that the drug not be given an expanded label. That's good news for AstraZeneca's (NYS: AZN) Brilinta and Eli Lilly's (NYS: LLY) Effient, which both treat acute coronary syndrome patients.

The panel of outside experts was worried about the large number of patients in the trial that were lost to follow-up. In a trial that spans multiple years, it's reasonable to expect that patients will drop out for reasons not related to the efficacy and safety of the drug, but it does confound the analysis.

The FDA rarely goes against an advisory committee's negative recommendation -- overruling a positive recommendation is much more common -- but this is one of the atypical times when I wouldn't be shocked to see the agency ignore the panel's negative advice. While the FDA pointed out the missing data in its briefing documents for the panel, the FDA reviewer ultimately said the drug looked approvable.

If the agency does reject the expanded indication, Johnson & Johnson and its partner Bayer will be left in a tight spot. They might be able to expend energy in tracking down the missing patients, but running another multiyear trial would be costly and might result in the same issue with a high level of dropouts.

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The article Have J&J's Approval Hopes Vanished? originally appeared on Fool.com.

Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. The Motley Fool owns shares of Johnson & Johnson. Motley Fool newsletter services have recommended buying shares of Pfizer and Johnson & Johnson. Motley Fool newsletter services have recommended creating a diagonal call position in Johnson & Johnson. The Motley Fool has a disclosure policy. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. Try any of our Foolish newsletter services free for 30 days.

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